Inviragen, Inc. today announced the initiation of a Phase 2, randomized, double-blind, placebo-controlled study of DENVax, the Company's investigational dengue vaccine. The Phase 2 trial will test the safety and immunogenicity of DENVax in multiple age groups in dengue endemic countries. The initiation of this Phase 2 study follows the successful conclusion of a Phase 1 study of DENVax that was conducted in Colombia in collaboration with PECET, the Program for the Study and Control of Tropical Diseases at Universidad de Antioquia. Data from this Phase 1 study demonstrate that the vaccine is safe and well-tolerated and immunogenic in dengue-naive adults; the results will be presented at the annual meeting of the American Society of Tropical Medicine and Hygiene (ASTMH) on December 7, 2011 in Philadelphia, PA.
“We are collaborating with leading clinical researchers in three continents to test the safety and immune responses to DENVax”
"Worldwide, dengue viruses infect young children as well as adults, causing devastating disease and tens of thousands of deaths every year," said Dr. Dan Stinchcomb, CEO of Inviragen. "This Phase 2 study will further assess the safety and immunogenicity of DENVax in adults as well as children in dengue endemic countries."
The Phase 2 clinical trial will evaluate safety and immunogenicity of DENVax, administered in two doses three months apart. In the first stage of the trial, individuals will be enrolled in four age groups: adults (aged 21 and older), adolescents (aged 11 to 20 years), pre-teens (aged 6 to 10 years) and children (aged 18 months to 5 years). An independent monitoring board will assess safety of the vaccine in subjects from each group before advancing to the next younger cohort. Following complete safety measurements in all four cohorts, the study will enter its second stage, enrolling hundreds of additional children aged 18 months to 11 years to further test the safety and immunogenicity of the two-dose DENVax vaccine.
Inviragen intends to enroll individuals in Puerto Rico, Colombia, Singapore and Thailand. "We are collaborating with leading clinical researchers in three continents to test the safety and immune responses to DENVax," commented Dr. Gilad Gordon, Inviragen's chief medical officer. "The data from this clinical study will provide the foundation for future large-scale Phase 3 efficacy studies to determine whether DENVax protects individuals from dengue fever in endemic countries."